Identity
- Trade Name
- AKR 800 EUDAMED
- Device Name
- AKR 800 EUDAMED
- Model / Reference
- AKR1JR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615020000441 EUDAMED
- Basic UDI-DI
- 361502000000IAKR8000000WG EUDAMED
- EMDN Code
- Z12120113 OPHTHALMOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Akr 800 by Essilor International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 361502000000IAKR8000000WG | Class I | Active |
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Manufacturer
- Manufacturer
- Essilor International
- EUDAMED SRN
- FR-MF-000007175
Sources (2)
- EUDAMED 33c11e35-23a3-4a8c-be6c-7a303696edfb 61 fields · synced Jul 18, 2026
- EUDAMED 8cb75c4c-598d-4e15-9581-9c34425ec67c 61 fields · synced Jul 18, 2026